On 25 April, regular meetings of the Scientific Expert Council and the Scientific and Technical Council took place at the Center under the chairmanship of the Center’s Director Mykhailo Babenko and Deputy Director for Registration and Pharmacovigilance Yevheniia Ishkova.
Following the review of registration materials submitted for state registration and re-registration of medicinal products, amendments to registration materials, and approval of clinical trial materials, this week the Center recommended:
- for registration – 14 medicinal products (3 of domestic and 11 of foreign manufacture) – products used in cardiology, urology, neurology, phthisiology, psychiatry and others;
- for registration of APIs – 3;
- for the re-registration of medicinal products (for an unlimited period) – 17;
- for re-registration of APIs – 6;
- for amendments to registration materials – 374 medicinal products (363 changes + 11 technical errors);
- withdrawal from the registration procedure – 1 medicinal products
- withdrawal from consideration at various stages of expert evaluation – 13 medicinal products.
Based on the results of the expert evaluation of materials on clinical trials of medicinal products, the following is recommended:
- before approval of the conduct of international multicenter clinical trials – 2 CTs (therapeutic group – oncology);
- approval of conducting domestic clinical trials – 1 clinical trials (bioequivalence studies of medicinal products)
- amendments to protocols of international multicenter CTs of medicinal products – 29 ( including those concerning treatment of coronavirus disease – 2).
Also, during the meeting of the Scientific Expert Council (SEC), the methodological recommendations “Specific Features of Conducting Clinical Studies of Medicinal Products for the Treatment of Urinary Incontinence” were considered and approved. A report was delivered by Lesia Yankova, Head of the Department of Clinical Audit of Clinical Trials of the Center.
